Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Rachel G Greenberg; Breck Gamel; Diane Bloom; John Bradley; Hasan S Jafri; Denise Hinton; Sumathi Nambiar; Chris Wheeler; Rosemary Tiernan; P Brian Smith; Jamie Roberts; Daniel K Benjamin Jr

doi:10.1016/j.conctc.2017.11.005

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Contemp Clin Trials Commun. 2017 Nov 23:9:33-39. doi: 10.1016/j.conctc.2017.11.005. eCollection 2018 Mar.

Authors

Affiliations

¹ Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC, 27705, USA.
² 401 Sagewood Drive, Hewitt, TX, 76643, USA.
³ Gillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.
⁴ Rady Children's Hospital, University of California San Diego, 3020 Children's Way, San Diego, CA, 92123, USA.
⁵ MedImmune, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
⁶ Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
⁷ Clinical Trials Transformation Initiative, 300 W. Morgan Street, Suite 800, Durham, NC, 27701, USA.

Abstract

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Keywords: ABDD; ABDD Peds Trials, Clinical Trials Transformation Initiative ABDD Pediatric Trials; ABDD, antibacterial drug development; ADHD, attention-deficit/hyperactivity disorder; Antibacterial; FDA, Food and Drug Administration; HPV, human papillomavirus; IRB, Institutional Review Board; Interview; MRI, magnetic resonance imaging; NICHD, National Institute for Child Health and Human Development; NIH, National Institutes of Health; Parental consent; Pediatric clinical trials; Recruitment.